Medical Writing Editor at Synteract

The Medical Writing Editor is responsible for providing technical writing and editing support of various regulatory and clinical research technical documents, including clinical trial protocols, clinical study reports, informed consent forms, investigator’s brochures, and other regulatory documents. Copy editor duties are focused on proofreading documents for text, content, and syntax consistency to facilitate the successful production and completion of such deliverables with quality. Provides communication support between medical writers, internal personnel, and clients. Provides quality review (QR) of documents as well as document finalization. Performs literature and reference research activities to support medical writers and regulatory professionals

Specific Tasks Would Include

• Primarily reviews, proofreads, edits, updates, corrects, formats, and makes improvement suggestions for project-related clinical study documents.
• Reviews material for grammar, spelling, punctuation, correct medical terminology, typographical errors, and formatting.
• Checks accuracy of content and ensures style consistency.
• Verifies data against original sources for quality control.
• Verifies correct implementation of internal and client changes.
• Ensures timelines are promptly met.
• Assists in compiling documents into a final product.
• Takes the initiative to be proactive and search out tasks before they are given.
• Performs data/content verification and reference checks information as required.
• Adheres to Synteract Style Guide, AMA style guidelines, or sponsor preferences.
• Interacts with internal specialists and Synteract consultants when appropriate.
• Participates in corporate initiatives and actions that ensure the continued success of the company.
• Provides a variety of technical skills, especially in programs such as Microsoft Office and Adobe Acrobat.
• May develop and maintain macros-enabled document templates.
• Maintains working knowledge of applicable industry guidelines and regulations.
• Maintains working knowledge, reviews, and updates departmental controlled documents as required.
• Other activities as designated.

Qualifications

• Bachelor’s degree or its international equivalent from an accredited institution.
• Scientific/technical background preferred.
• 2 to 4 years of related experience (clinical trials, publishing, writing, or editing), with at least three years of medical editing experience in a regulated environment, preferably in the pharma/biotech/CRO sector.
• Experienced in Microsoft Office and Adobe Acrobat.
• Working knowledge of GCP, ICH and FDA Guidance Documents/EU Directives/ISO14155 regulations and/or drug/device development.
• Demonstrated knowledge of web-based communication tools and various technical programs, including but not limited to Adobe, Microsoft Office, etc.
• Strong knowledge of AMA style guidelines.
• Demonstrated mastery of grammar, punctuation, and spelling.